Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).
The main question[s] it aims to answer are:
• How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%?
Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.
详细描述
Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected randomly and applied per the protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that have been previously divided equally according to sample size arms. The selected envelope is then opened by the operator, who applies either the EC or BC topical anesthesia technique based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is then observed and assessed by the blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children (ASA I) aged between 7 - 10 years old.
- •Needing any maxillary buccal infiltration (anterior, middle, posterior)
- •Had no prior history of local anesthesia.
- •Frankl behavior III or IV
- •Not taking any painkillers, or other drugs that would influence with their pain perception.
排除标准
- •History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.
- •Active pathology at the site of injection.
- •Prior history of intra-oral injection.
- •Frankl behavior I or II.
- •Children/parents not willing to participate in the study. § Needle phobia.
- •Patients require treatment under conscious sedation.
结局指标
主要结局
Heart rate
时间窗: 5-10 minutes
Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.
次要结局
- Visual Analog Scale (VAS)(5-10 minutes)
- Face Pain Scale(5-10 minutes)
- Sound, Eye, Motor (SEM) Index(5-10 minutes)
研究者
Nagah ABdelrahman
Principal Investigator
Mohammed Bin Rashid University of Medicine and Health Sciences